Ive been looking a little closer at kaiser and it seems to me they would probaly NOT take on cxbladder if they thought they wouldnt achieve LCD.
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Ive been looking a little closer at kaiser and it seems to me they would probaly NOT take on cxbladder if they thought they wouldnt achieve LCD.
Can I just ask the obvious on LCD please
Is this where an insurer provides this as a preventative test for their members to help limit the potential issues downstream if no testing was done?
From memory and I can’t remember who was doing it but PEN was already providing tests currently not paid and once approved I think it was well over $4 in non banked Payments once approved
Would appreciate any updates on this
I wrote to Pacific Edge querying this announcement at the time and asking where the NCCN guidelines referenced CxBladder.
They replied
The NCCN guidelines themselves don’t explicitly refer to Cxbladder, or any of the markers for that matter.
The reference cited in the guidelines which refers to Cxbladder is a review article by Chou et al (2015).
It is not the most compelling of reviews, and we are a little surprised that it has substantiated the move in the NCCN guidelines.
We’re not complaining though, and would expect further movement in aspects of the guidelines based on more recent publications.
I replied:
Seems to me that the latest NZX announcement by PE is very misleading.
“ The NCCN Bladder Cancer Panel considers this a category 2B recommendation, which means there is NCCN consensus that the use of Cxbladder as a clinical intervention is appropriate”
It is a bit of a stretch to say that the NCCN are recommending the use of CxBladder as appropriate surely? Use is not actually suggested in the guidelines, at most it receives a passing mention in a referenced literary study which does not seem supportive of the urinary markers considered at all! Strength of evidence for Cxbladder was low (one study written by Pacific Edge, medium risk of bias). It concludes “urinary biomarkers miss a substantial proportion of patients with bladder cancer and are falsely positive in others”.
I’d appreciate further clarification.
I received no further clarification
I'm hoping this latest news regarding Kaiser is not more puffery.
Most of these articles being referred here are from Mid last year.
The latest announcement posted on NZX specifically refers to an agreement/approval by Kaiser Permanente.
If anyone has been in touch with PE, since the announcement it would be great to hear from them.
"KAISER PERMANENTE APPROVES COMMERCIAL USE OF CXBLADDER
Cancer diagnostics company, Pacific Edge Limited (NZX: PEB) and US healthcare provider, Kaiser Permanente, have reached agreement for the commercial use of Pacific Edge’s Cxbladder tests.
Kaiser Permanente has approved the commercial use of Cxbladder by their urologists for patients being evaluated for bladder cancer. "
Good to see you back Psychic.
Think this is getting to the water under the bridge phase.
Its hardly an up to date analysis with a paper from 5 years ago.
Just goes to show how much time is needed to get this data up front and in their faces
Mind you when you look at the acres and acres of different tests for everything under the sun its a wonder anything gets approved.
Treacle alright.
Would have to say that PEB seems to have learnt the lesson not to over-promise and then, under-deliver by its historical long shot if one looks and assesses this announcement about Kaiser Permanente (KP).
There was no reference made of KP when the company announced its results on 29 May :
https://www.nzx.com/announcements/353944
Rather surprising as PEB had been highlighting KP in previous announcements as being in various stages of negotiations.
The spike in the sp should certainly reinforce for PEB to not over-promise on LCD inclusion but let the results speak for themselves.
Certainly food for thought - will the sp race away as dramatically, if PEB announces it has received LCD inclusion, as it has with the KP deal?
LCD are local coverage determinations
They are issued by Medicare/MedicAid providers locally and centrally.
What it means is that Medicare and other "state equivalent" health providers (as opposed to private like Kaiser) will pay for the test/procedure.
They value it of enough worth as a genuine medical test that they give it a NUMBER. And the USA is all about numbers.
It may be that PEB are well into this as it looks like bladder cancer Dx and Px molecular tests have come up on the CMS meeting schedule going on right now: https://www.cms.gov/Medicare/Coverag...onProcess/LCDs
It will be one-off revenue surge for the fiscal year plus some more recognised CMS commercial tests. It is very fruitful... :-)
Do you guys know how the cost of all unrecognised revenues was booked in the financial statement? Would it be a part of investment activities or expenses?